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Sponsored by: |
Nabi Biopharmaceuticals |
Information provided by: | Nabi Biopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00211978 |
The purpose of this study is to determine if calcium acetate (PhosLo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.
Condition | Intervention | Phase |
Hyperphosphatemia Kidney Failure |
Drug: calcium acetate Drug: placebo |
Phase III |
MedlinePlus related topics: | Kidney Failure |
ChemIDplus related topics: | Calcium gluconate Acetic acid, calcium salt Phosphorus |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | EPIC (Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease): A Prospective, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel Arm, Study of PhosLo on Phosphorus Levels in Subjects With Chronic Kidney Disease |
Enrollment: | 110 |
Study Start Date: | May 2005 |
Study Completion Date: | October 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
PhosLo: Experimental |
Drug: calcium acetate
667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)
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placebo: Placebo Comparator |
Drug: placebo
gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)
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In patients with impaired kidney function, dietary phosphorus can not be completely excreted, which leads to elevated levels of serum phosphorus. Elevated serum phosphorus leads to increased levels of parathyroid hormone (PTH), and is associated with bone disease and other adverse consequences such as soft-tissue and vascular calcification, and increased morbidity and mortality. It is therefore important to prevent hyperphosphatemia and maintain serum phosphorus levels within the range recommended by K/DOQI. In patients on dialysis, phosphate binders are routinely used to control serum phosphorus by absorbing dietary phosphate during the transit through the intestine. However, the use of phosphate binders for non-dialyzed patients with chronic kidney disease (CKD) is not an FDA approved indication, although some physicians treat patients prior to dialysis based on clinical judgment. The goal of this study is to demonstrate the efficacy of calcium acetate (PhosLo) in controlling serum phosphorus in patients with moderate to severe decrease in kidney function.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |||||
University of Texas Health Sciences Center | |||||
San Antonio, Texas, United States, 78229-3900 |
Nabi Biopharmaceuticals |
Study Chair: | Wajeh Y Qunibi, M.D. | University of Texas Health Science Center, San Antonio |
Responsible Party: | Nabi Biopharmaceuticals ( Paul Kessler, MD, Sr. VP, Clinical, Medical, & Regulatory Affairs ) |
Study ID Numbers: | Nabi 6402, EUDRACT# 2005-002565-36 |
First Received: | September 13, 2005 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00211978 |
Health Authority: | United States: Food and Drug Administration |
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